Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.

NCT04631315 | Completed Phase 4 FDA Drug

• 1 other identifier: DIFLUPRED03
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled, randomized, double blind, multicenter study will be carried out to demonstrate that the topical ophthalmic nanoemulsion of difluprednate 0.05% (Tolf®, Poen Laboratories), has a high anti-inflammatory efficacy, which would allow it to be administered after cataract surgery 1 drop, twice a day , starting the day before surgery and continuing for 14 days and 1 drop, once a day for the following 2 weeks, achieving an adequate anti-inflammatory activity, with the benefit of reducing the toxicity on the ocular surface, improving the dosage and adherence to treatment. The follow-up time will be 28 days and the outcome measures will be evaluated in a baseline (time 0), on day 1, on day 4 and on day 28 after surgery. The active control will be prednisolone acetate 1% + phenylephrine hydrochloride 0.12% topical ophthalmic suspension (Prednefrin® Forte, Allergan Argentina) given 1 drop, 4 times a days and 1 drop, twice a day for the next 2 weeks. Corneal thickness, central macula thickness, endothelial cell count, intraocular pressure, visual acuity, anterior chamber clearance and lacrimal film recovery will be evaluated.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Change from baseline corneal thickness between treatments

  Demonstrate that 0.05% difluprednate ophthalmic nanoemulsion administered 1 drop, 2 times a day, beginning the day before cataract surgery and continuing for the first 14 postoperative days and then 1 drop, once a day for the next 14 days, it does not present an anti-inflammatory efficacy lower than treatment with prednisolone acetate 1% + phenylephrine hydrochloride 0.12% ophthalmic suspension administered 1 drop, 4 times a day starting the day before surgery and continuing during the first 14 post-surgical days and 1 drop , 2 times a day for the next 14 days, for the treatment of postsurgical inflammation, in patients operated on for N2 and N3 cataracts. Difluprednate 0.05% ophthalmic nanoemulsion will not be clinically inferior than Prednisolone acetate 1% + 0.12% phenylephrine hydrochloride ophthalmic suspension, if the difference in corneal thickness obtained with OCT between the baseline day and the post-surgical day it does not differ beyond 17 µm between treatments.

  Baseline to visit 3 (96 hours from surgery)

Secondary Outcomes (7)

• Retinal Thickness

  Day before surgery (-1); Day 1 after surgery (1); Day 4 after surgery (4); 28 days post surgery (28)

• Corneal endothelial cell count

  Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

• Visual acuity

  Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

• Flare and cell on anterior chamber

  Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

• Intraocular pressure

  Day before surgery (-1); Day after surgery (1); Day 4 after surgery (4); 28 days post surgery (28).

Study Arms (2)

Intervention

EXPERIMENTAL

Difluprednate Ophthalmic Emulsion 0.05%

Drug: Difluprednate Ophthalmic Emulsion 0.05%

Comparator

ACTIVE COMPARATOR

Prednisolone Acetate 1% - Phenylephrine 0.12% Ophthalmic Suspension

Drug: Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution

Interventions

Difluprednate Ophthalmic Emulsion 0.05% DRUG

1 drop, 2 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, once a day for the next 2 weeks.

Also known as: Tolf®

Intervention

Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution DRUG

1 drop, 4 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, twice a day for the next 2 weeks.

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes between 45 and 65 years old (women who are not fertile) who undergo cataract surgery N2 and N3, defined according to BCN10, Decimal classification of cataracts.
• That the surgical technique is ultrasonic phacoemulsification.
• Patients who have an initial corneal thickness between 500 and 570 µm inclusive.
• Patients with initial intraocular pressure between 12 and 18 mm Hg inclusive.
• Patients with an endothelial cell count greater than 1000 cells / mm2

You may not qualify if:

• Patients who use eye medication, except eye lubricant.
• Patients who before surgery have not been able to dilate their pupil more than 5 mm
• Patients who have been treated with corticosteroids or systemic anti-inflammatory drugs for 2 weeks prior to enrollment
• Patients who have received periocular corticosteroid injections in the study eye within the previous 4 weeks or used depot corticosteroids within 2 months prior to enrollment
• Patients who have received a topical ocular corticosteroid or non-steroidal anti-inflammatory drug (NSAID) within 24 hours prior to enrollment
• History of glaucoma or ocular hypertension in the study eye, history or presence of endogenous uveitis, or corneal abrasion or ulceration
• Patients with a diagnosis or suspicion of keratoconjunctival disease caused by viruses, bacteria, or fungi
• Patients which presents an allergy to the drug to be tested or to any similar drug such as other corticosteroids
• History of increased intraocular pressure due to the use of corticosteroids
• Patients with pathological macular features
• Diabetics
• Breastfeeding women
• Patients with rheumatoid arthritis.
• Patients treated with Amiodarone

Sponsors & Collaborators

• Laboratorios Poen: lead

Study Sites (1)

Laboratorios Poen

Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., C1407BDR, Argentina

Location

MeSH Terms

Conditions

Cataract

Interventions

OmpF protein; prednisolone acetate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Jorge Tosi, M.D.

  Laboratorios Poen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 17, 2020
• Study Start: March 24, 2019
• Primary Completion: May 24, 2020
• Study Completion: July 21, 2020
• Last Updated: May 12, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)